(76 days)
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No
The description focuses on mechanical components and fluid dynamics, with no mention of computational analysis, algorithms, or learning capabilities.
No
The device is an administration set with a needle-free valve used for delivering IV fluids and adding medication to the line, but it does not directly treat or diagnose a disease or condition.
No
Explanation: The device description states its intended use is for "IV fluid delivery" and "to add medication into the primary line." It describes a mechanical valve action for fluid administration, not for detecting, monitoring, or diagnosing a medical condition.
No
The device description clearly details physical components like valves, pistons, and connectors, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "IV fluid delivery of a wide range of fluids" and allowing "the user to add medication into the primary line without the use of a needle." This describes a device used for administering substances directly into a patient's bloodstream.
- Device Description: The description details the mechanical function of a valve for fluid administration and medication injection. It focuses on the physical components and how they facilitate fluid flow and prevent leakage.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device described is a component of an intravenous administration system, which is a medical device used for patient treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The intended use for the IVAC Needle Free Valve administration sets is to allow IV fluid delivery of a wide range of fluids. The needle free valve allows the user to add medication into the primary line without the use of a needle.
Product codes
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Device Description
The IVAC Needle Free Valve administration sets incorporate standard IVAC set components using standard materials. The sets include a needle free valve that allows the user to add medication into the primary line without the use of a needle. When the valve is in the closed position it has a flat smooth surface for cleaning. When the male connector of a syringe or secondary line is pushed into the valve the rubber piston inside the valve is compressed. The top of the rubber piston is then allowed to expand into the increased diameter inside the valve. Fluid path is achieved through the male connector into the center of the rubber piston and the valve housing. When the male connector is removed from the valve, the bellows section of the piston provides a spring force to return the piston to the top of the valve and to maintain a sealed fluid path. A cap is not required to maintain sterility.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
ICU Medical, Inc. Clave Connector
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
APR - 4 1996
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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- SUBMITTER'S NAME: IVAC CORPORATION 10300 Campus Point Drive San Diego, CA 92121-1579 (619) 458-7825
- CONTACT PERSON: Jennifer S. Hankard Sr. Manager of QA/RA
DATE PREPARED: January 17, 1996
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- DEVICE NAME: Proprietary Name: IVAC Needle Free Valve Administration Sets
Common Name: Intravascular Administration Set
- DEVICE NAME: Proprietary Name: IVAC Needle Free Valve Administration Sets
Classification Name: Intravascular Administration Set
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- PREDICATE DEVICE: ICU Medical, Inc. Clave Connector
- ব . DEVICE DESCRIPTION: The IVAC Needle Free Valve administration sets incorporate standard IVAC set components using standard materials. The sets include a needle free valve that allows the user to add medication into the primary line without the use of a needle. When the valve is in the closed position it has a flat smooth surface for cleaning. When the male connector of a syringe or secondary line is pushed into the valve the rubber piston inside the valve is compressed. The top of the rubber piston is then allowed to expand into the increased diameter inside the valve. Fluid path is achieved through the male connector into the center of the rubber piston and the valve housing. When the male connector is removed from the valve, the bellows section of the piston provides a spring force to return the piston to the top of the valve and to maintain a sealed fluid path. A cap is not required to maintain sterility.
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- INTENDED USE: The intended use for the IVAC Needle Free Valve administration sets is to allow IV fluid delivery of a wide range of fluids. The needle free valve allows the user to add medication into the primary line without the use of a needle.
1
6. TECHNOLOGICAL CHARACTERISTICS:
The IVAC Needle Free Valve administration sets and the ICU Medical, Inc. Clave Connector use the same method of manufacture, incorporate standard set components, and use standard materials. The primary function of the IVAC Needle Free Valve administration sets is the same as the ICU Medical, Inc. Clave Connector: to allow the user to add medication into the primary line without the use of a needle. The technological characteristics of the devices are the same and raise no new questions of safety and effectiveness. IVAC Corporation concludes that the IVAC Needle Free Valve administration sets are substantially equivalent to the ICU Medical, Inc. Clave Connector.